Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
NCT ID: NCT03035721
Last Updated: 2017-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2014-06-30
2016-06-30
Brief Summary
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Detailed Description
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To investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula.
Anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.
The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Low protein formula group
Full term healthy infants randomized to receive a low protein formula for the first 4 months of life
Low protein formula
Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.
Standard protein formula group
Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life
Standard protein formula
Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.
Breastfeeding group
Breastfed full term healthy infants
No interventions assigned to this group
Interventions
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Low protein formula
Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.
Standard protein formula
Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.
Eligibility Criteria
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Inclusion Criteria
* singleton
* full-term infants (gestational age 37/0 to 41/6 weeks)
* birth weight adequate for gestational age (\>p10 and \<p90 for gestational age) according to the World Health Organization growth charts.
Exclusion Criteria
* presence of chromosomal abnormalities
* presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
* being born to mother affected by endocrine and/or metabolic diseases
* having a family history of allergic disease
1 Day
3 Weeks
ALL
Yes
Sponsors
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Humana Co.Ltd.
INDUSTRY
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Paola Roggero, MD
Role: PRINCIPAL_INVESTIGATOR
NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
Locations
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NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
Milan, , Italy
Countries
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References
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Liotto N, Orsi A, Menis C, Piemontese P, Morlacchi L, Condello CC, Gianni ML, Roggero P, Mosca F. Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.
Other Identifiers
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Low protein formula_RCT
Identifier Type: -
Identifier Source: org_study_id